SUMMED HIGH PRESSURE LINE by SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD

The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

Device Description

The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.

Package: Material: Dupont Tyvek package for medical use.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Sunmed™ High Pressure Line." It seeks to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study. Therefore, much of the requested information about acceptance criteria for a novel device and specific study types (like MRMC or standalone performance) is not applicable or present in this filing.

However, I can extract the relevant information regarding the non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on your request, explaining why some sections are not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating the device performs comparably to legally marketed predicate devices, especially through non-clinical testing. The "reported device performance" refers to the successful completion of these non-clinical tests.

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance (Successful Testing)
Biocompatibility:
- Absence of pyrogenic response	Pyrogen Test: Passed
- Absence of acute systemic toxicity	Acute Systemic Toxicity Test: Passed
- Absence of intracutaneous reactivity	Intracutaneous Reactivity Test: Passed
- Absence of in vitro cytotoxicity	In Vitro Cytotoxicity Test: Passed
- Absence of skin sensitization	Skin sensitization Test (two kinds of solvent): Passed
- Acceptable hemolytic response	In Vitro Hemolysis Study (ASTM F756-08): Passed
Material/Device Integrity:
- Resistance to aging effects	Aging Testing: Passed
- Mechanical/functional integrity	Bench Testing: Passed
Sterility:
- Maintenance of sterile barrier	Package Penetrate Testing: Passed
- Sterility assurance	Asepsis Testing: Passed
- Acceptable residual levels	EtO and ECH Residue Testing: Passed
Equivalence in Technological Characteristics
- Intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, method of sterilization equivalent to predicate devices.	Detailed comparison provided, concluding identical technological characteristics.

Study Details

Given this is a 510(k) for a device like a high-pressure line, the "study" is primarily a non-clinical bench and lab testing program designed to demonstrate substantial equivalence, not a clinical trial.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each non-clinical test. These tests typically use a defined number of device units as per specific test standards (e.g., ISO or ASTM standards).
- Data Provenance: The tests were performed by or for Sunny Medical Device (Shenzhen) Co., Ltd. The physical location of testing is not specified beyond the company's address in Shenzhen, China. This would be considered retrospective data in the context of this submission, as the tests were completed prior to the FDA review.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this type of non-clinical device testing. "Ground truth" and expert consensus are concepts typically applied to diagnostic algorithms or subjective assessments in clinical settings. Here, "ground truth" is defined by adherence to established testing standards and objective measurements (e.g., passing a sterility test or showing no toxicity).
Adjudication method for the test set:
- Not applicable. Adjudication relates to resolving discrepancies in human expert opinions, which isn't part of non-clinical bench testing. The results of these tests are objective measurements against predefined acceptance criteria from standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a passive high-pressure line, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no "algorithm" in this device. Its performance is mechanical and biocompatibility-based.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" is established by objective scientific standards and measurements (e.g., absence of bacterial growth, specific chemical residue levels, lack of a toxic response in biological assays, structural integrity under pressure). It's not based on expert consensus, pathology, or outcomes data in the traditional sense, but adherence to recognized test methodologies and their pass/fail criteria.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" as it's not an AI/machine learning product. Performance is based on physical and biological testing of manufactured units.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2015

Sunny Medical Device (Shenzhen) Co., Ltd. Mr. James Oi Zhang General Manager 56 Lehigh Aisle Irvine, California 92612

Re: K140356

Trade/Device Name: Sunmed High Pressure Line Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: February 2, 2015 Received: February 18, 2015

Dear Mr. Zhang,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M.A. Hilleman

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. Indications for Use Statement

Indications for use

510(k) Number (if known): K140356

Device Name: Sunmed™ High Pressure Line

Indications for Use:

文 Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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1. 510(k) Summary

1.	Submitted by:	Sunny Medical Device (Shenzhen) Co., Ltd.
	Registered Address:	4/F and 5/F, Dongpingxing Creative Science Park,Longgang District, Shenzhen,Guangdong, P.R. China 518172
	Contact Address:	56 Lehigh AisleIrvine, CA 92612
	Telephone:	(949) 216-8838
	Fax:	(949) 423-0168
	Contact:	James Qi Zhang, General Manager
	E-mail:	jamesqizhang@gmail.com
	Date:	Nov. 18, 2013

1. Proposed Device:

Trade/Proprietary Name:	Sunmed™ High Pressure Line
Common/Usual Name:	Disposable High Pressure Line
Classification:	II
Classification Name:	Diagnostic intravascular catheter
Regulation Number:	870.1200
Product Code:	DQO

1. Predicate Device:

510(K)Number	Trade or Proprietary or Model Name	Manufacturer
K071196	Disposable High Pressure InjectionLines and without Rotating Adapters	Coeur Medical, a divisionof Coeur Inc.
K023591	Ultra High Pressure Injector Lines	DeRoyal Industries, Inc.

Sunny Medical Device (Shenzhen) Co., Ltd.

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1. Device description
  The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.

Package: Material: Dupont Tyvek package for medical use.

1. Intended Use
  The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer (including rotating male luer), and tubing and with or without caps.
Technological Comparison to Predicate Device 6.
The technological characteristics of the subject device, The Sunmed™ High Pressure Line, are equivalent to Disposable High Pressure Injection Lines and without Rotating Adapters and Ultra High Pressure Injector Lines in terms of intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.
1. Summary of the technological characteristics of our device compared to the predicate device:
  The predicates were compared in the following areas and found to have identical technological characteristics and to be equivalent because they are the identical products.

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Indications for Use Material Components Technique (Components/Flexible/Packaging/Pressure ) Sterility Biocompatibility

1. Summary of Non-Clinical Testing
  The following tests were performed on the Sunmed™ High Pressure Line:

Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test Intracutaneous Reactivity Test In Vitro Cytotoxicity Test Skin sensitization Test (two kinds of solvent) In Vitro Hemolysis Study( ASTM F756-08) Aging Testing Bench Testing Package Penetrate Testing Asepsis Testing EtO and ECH Residue Testing

1. Clinical Evaluation was not applicable.

10. Conclusions

Based on the information presented in this 510(k) premarket notification, the SunmedTM High Pressure Line is considered substantially equivalent to the Disposable High Pressure Injection Lines with and without Rotating Adapters and Ultra High Pressure Injector Lines.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).